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Saturday, February 8, 2014

Multiple Sclerosis is an autoimmune disease that affects the brain and spinal cord, destroying tissue and cells along the way. Now, scientists may have found a a new therapeutic target for MS. (Photo : David Foltz)

Multiple Sclerosis is an autoimmune disease that affects the brain and spinal cord, destroying tissue and cells along the way. Previous research and practices have found that therapies can help with relapses of MS, but cannot help repair the tissue and cells that have been affected.

ittorio Gallo, PhD, is the Director of the Center for Neuroscience Research at Children's National Health System. He and his researchers believe to have found what they call a "potentially novel therapeutic target." This would not only lessen the rate of deterioration of brain cells caused by MS, but it would help new growing cells complete the repair of the previously damaged ones.

After MS has affected the body and caused cell damage, the brain produces new cells to repair the old ones. However, a majority of cases has shown that there are unknown factors that hinder the cells from completely repairing, thus creating a permanent loss. The brain inflammation caused by MS leads to the destruction of myelin, which is the fatty insulation for the axon nerve fibers in the brain, thus destroying brain cells. A molecule known as Endothelin-1 (ET-1) is known to inhibit the repair of the myelin.

Yesterday, Gallo and his team of researchers reported their findings in Neuron and cited the effectiveness of a certain protein that could help fully repair previously damaged cells. This protein, known as "ET-R antagonist PD142,893" can be used therapeutically to promote remyelination and effectively block ET-1 from inhibiting cell repair.

"We demonstrate that ET-1 drastically reduces the rate of remyelination," Gallo said. "ET-1 is potentially a therapeutic target to promote lesion repair in deymyelinated tissue. It could play a crucial role in preventing normal myelination in MS and in other demyelinating diseases," Gallo said in this Children's National Health System article.

To read more about Dr. Gallos study, visit the link above as well as yesterday's published study in Neuron.

Researchers continue to explore different treatment approaches for secondary progressive MS, ranging from the development of new immunotherapeutic drugs that foster myelin repair and neural protection to immune suppressing drugs that stem the tide of progressive symptoms and advancing debility that typically occurs with the disease. Researchers at the Collaborative MS Research Center at the University of California at San Francisco are working on several different treatment approaches, as well as seeking to develop molecules that may be used as biomarkers to help doctors predict MS progression before it occurs.

However, for those MS patients who have already been diagnosed with secondary progressive MS, the Center’s research into use of the drug Natalizumab may offer particular hope for a definitive treatment for the disease.

The current study involving Natalizumab seeks to determine whether the drug is particularly efficacious in reducing the progression of disability for patients who already have secondary progressive MS. It is a relatively large study involving 156 different site locations throughout the world, and the fact that the study is Phase 3b suggests that the use of the drug in treating SPMS has shown enough success in previous studies to be cleared for testing across a wide range of participants.

The study will use a randomized, double-blind, placebo-controlled approach for approximately 856 SPMS subjects whose disease has clearly progressed to the point where symptoms no long come in waves, but are sustained — the defining feature of secondary progressive MS. The participants in the study will be randomized to receive either natalizumab 300 mg or placebo intravenously (IV) every 4 weeks (q4wk) for 96 weeks, and participants must be between the ages of 18 and 58, inclusive, with a diagnosis of SPMS for at least 2 years, an EDSS score between 3.0 and 6.5, inclusive, and documented evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment, and who are naïve to Natalizumab.

In point of fact, while Natalizumab may not be commonly known in the MS community — to date, it has generally been used only as a last-resort medication for non-relapsing patients who have tried other drugs to no avail –it is used to treat Crohn’s disease as well. The reason for this is that, while the drug was initially approved by the FDA in 2004, was approved in 2004 after many years of testing, the drug was later linked in three cases of the rare neurological condition progressive multifocal leukoencephalopathy (PML) when administered in combination with interferon beta-1a. Because interferon is typically used as an MS treatment option, the drug was pulled from the market. In this way, Natalizumab has offered middling results, much in the same way that most drugs do during their clinical trials.

The most recent clinical work done on the drug involving secondary progressive MS, however, has been promising. An article in MedScape from 2012 revealed promising results for Natalizumab in progressive MS, with the drug’s Phase 2 study revealing that the drug (this study used the Natalizumab brand Tysabri, from Biogen Idec) reduced inflammation, axonal damage, and demyelination in patients with progressive multiple sclerosis (MS). This was a particularly important study, since inflammation, axonal damage, and myelin repair are all key elements to what will eventually lead to a successful treatment option for secondary progressive MS.

despite the new late-phase study for Natalizumab, the drug undoubtedly has farther to go before it can be claimed as a true breakthrough treatment for SPMS. However, in spite of a few setbacks in testing, the DFA and research community still consider the drug to be a viable option.

Symptoms & Diagnosis of SPMS

SPMS symptoms are not necessarily different from the symptoms that govern Multiple Sclerosis overall; the defining feature of the disease type is its shift in pattern. However, symptoms associated with Secondary Progressive MS include an increase in weakness and lack of coordination; stiff, tight leg muscles; loss of bowel and bladder control; and increased fatigue, depression, and problems thinking than before — all of which do not appear to come and go.

As noted above, SPMS diagnosis is predicated on steady communication between patient and doctor, since the diagnosis is not made via a diagnosis assay, but rather through professional observation and tracking of the disease. While the diagnosis may seem subjective, updating a diagnosis from Relapsing-Remitting to Secondary Progressive is very important, since the approach to treatment may change as well. In order to get the most informed diagnosis for Secondary Progressive MS, doctors use the Kurtzke disability scale to aid the measurement of the disease progression.

Causes of Secondary Progressive MS

One of the key areas of research for MS is an understanding of why Relapse-Remitting Multiple Sclerosis eventually progresses into Secondary Progressive MS in so many cases, as the cause of this is still largely unknown. Early theories suggested that the progression was linked with increased immune responses — an idea that has since given way to a more plausible theory that the progression of the disease may be a result of nerve damage or loss. Researchers believe that bringing to light a better understanding of the progression of MS will ultimately lead to improved treatments in the future.

Secondary Progressive MS: What You Need To Know

Multiple Sclerosis (MS) is a disease that features several distinct patterns of increasing disability over time. One of the four most common disease courses, Secondary Progressive Multiple Sclerosis (SPMS), often comes after an MS patient has first been diagnosed with and suffered from a period of relapsing-remitting multiple sclerosis. While relapsing-remitting MS is characterized by a series of unpredictable attacks or flare-ups that subside into a remission state, the increasing disability pattern of secondary progressive MS becomes more steady over time, with flare-ups giving way to a steady increase in disability and loss of quality of life.

It is estimated that about 90% of patients who are initially diagnosed with relapsing-remitting MS will eventually see the disease develop into secondary progressive MS. Typically, the transition from relapsing-remitting MS to the secondary progressive form begins about ten years or more from the initial diagnosis, as this is when patients most often report changes in their symptoms and the arc of the severity of the disease.

Though the chart at the left generalizes the progression of several types of MS, because the disease and the manner in which if affects patients is so variable, offering a diagnosis of Secondary Progressive MS can take six months or more, in order for physicians and patients to track the increasing symptoms and disability patterns.

Secondary Progressive MS: Understanding The Patterns

While there is no pattern to predicting attacks in Relapsing-Remitting MS, the overall pattern of the disease type, which features an ongoing series of attacks and remission periods, is enough to differentiate it from other MS diagnoses, such as Primary Progressive Multiple Sclerosis, which features a steady progression of symptoms and disability from the start of the disease. As Relapsing-Remitting MS has a definable pattern feature, patients are able to notice the shift to the progressive form of the disease as it has become palpable over the course of time, since there is no longer a “recovery” period from symptoms.

New Zealand-based Innate Immunotherapeutics has been in the news as of late, making headlines about the drug developer’s innovative R&D into testing and developing a viable treatment option for secondary progressive multiple sclerosis. Most recently, new reports of the company’s lead experimental drug for secondary progressive multiple sclerosis, MIS416, has revealed promising results in studies led by researchers at Victoria University of Wellington.

The study, which was conducted at Victoria and published online in PLOS ONE, revealed that Innate Immunotherapeutics’ MIS416, developed originally to treat the relapsing-remitting form of MS, has been shown to help patients with secondary progressive MS as well. The team of researchers, which includes Dr. Anne La Flamme, Associate Professor in Victoria’s School of Biological Sciences and head of the MS Research Programme at the Malaghan Institute of Medical Research, Dr. Gill Webster from Innate Immunotherapeutics, and PhD student Madeleine White, admit that while their study proved that the drug is indeed efficacious in the treatment of secondary progressive multiple sclerosis, the team still does not fully understand what makes the therapy effective.

“We know this drug works, but we are not sure why,” Dr La Flamme said. ”This study has helped us understand the pathways that are driving the disease and how the medication alters the immune system, giving us a better idea of why MIS416 works as well as insight into how to treat patients and predict who will do better on this sort of medication.”

Dr. La Flamme went on to explain that the majority of cutting-edge research into the treatment of MS is focused on T-cells. However, the new Victoria study reveals that targeting other cells in the central nervous system can significantly reduce advanced forms of MS, such as secondary progressive multiple sclerosis.Secondary Progressive Multiple Sclerosis.

Opexa Therapeutics is currently recruiting nationwide for a clinical trial of its investigational therapy for the treatment of Secondary Progressive Multiple Sclerosis. Get more information about the trial by clicking the icon below:

Friday, February 7, 2014

Tcelna® (imilecleucel-T)

Tcelna® (formerly known as Tovaxin) is a personalized T-cell immunotherapy in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive Multiple Sclerosis. Tcelna is specifically tailored to each patient's immune response profile to myelin and is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) known to attack myelin. Tcelna is manufactured using ImmPath™, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

Fast Track Regulatory Approval

Tcelna® has been granted Fast Track status by the U.S. FDA in Secondary Progressive MS (SP-MS) based on the unmet need of the progressive indication and the potential of Tcelna to benefit this patient population. Opexa has also completed formal End of Phase II meetings with the FDA and has received support to move forward with the design of pivotal Phase III clinical trials in Relapsing Remitting MS (RR-MS). Opexa is currently conducting a Phase IIb clinical trial in SP-MS patients and continues to evaluate its plans in the RR-MS indication.

Tcelna® Differentiation

Tcelna® possesses a unique mechanism of action that combats the demyelination of the nerve fibers in the central nervous system, the underlying cause of MS. Five clinical trials have been completed with Tcelna in 356 patients, many with multiple years of treatment. Opexa believes Tcelna may possess a number of advantages compared to other MS therapies currently available or in development, including:

Personalization - Tcelna® is a personalized autologous immunotherapy that is manufactured for every individual patient, tailored to his or her immunity to myelin. Each patient receives a newly personalized treatment on an annual basis based on their unique epitope profile. Opexa is unique in that it evaluates 109 peptides across the three key myelin proteins to identify each patient's set of dominant epitopes.

Efficacy - Clinical trials conducted to date demonstrate that Tcelna® may result in a reduction in the Annualized Relapse Rate (ARR) for patients with MS, slowing of disease progression and evidence of an improvement in disability in a number of MS patients, which could suggest a neuroprotective benefit.

Safety and Tolerability - It is believed that Tcelna® treatment selectively targets and regulates the pathogenic T-cell population. It is not a general immune suppressant and, accordingly, is not associated with the serious side effects seen by those MS treatments that function by systemically suppressing the immune system. In clinical trials conducted to date, the safety profile of Tcelna has remained superb.

Improved Compliance - Currently, available therapies are administered monthly and, in some cases, daily. The treatment regimen for Tcelna® consists of only five subcutaneous injections per year, which we believe may provide compliance benefits to patients and physicians.

Clinical Development in SP-MS

Patients with Secondary Progressive MS (SP-MS) represent approximately 50% of the total MS population, yet treatment options remain very limited. Currently, there is only one product specifically approved for patients with SP-MS, and that product carries a black box warning due to severe cardiotoxicity. In an effort to meet this significant unmet medical need, Opexa is currently conducting a Phase IIb clinical trial of Tcelna® in SP-MS patients.

A new treatment that boosts immunity to Epstein-Barr virus may benefit patients with multiple sclerosis, according to the results of an Australian study published in the Multiple Sclerosis Journal.

In their study report, Michael Pender, a professor at the University of Queensland School of Medicine, Brisbane, and colleagues describe how a patient with advanced multiple sclerosis (MS) experienced noticeable clinical improvement after receiving 6 weeks of the immunotherapy treatment.

MS is an inflammatory disease, where the body's own immune system attacks and destroys myelin, the protein that insulates the nerves in the spinal cord, brain and optic nerve and stops the electrical signals they convey from leaking out.

As the disease advances, symptoms progress from mild numbness in the limbs to paralysis and blindness.

Estimates from the National Multiple Sclerosis Society suggest MS affects around 400,000 Americans. In Australia, the number of people affected by the disease is thought to be over 23,000.

Epstein-Barr virus (EBV) is a virus of the herpes family and one of the most common viruses in humans. It affects 9 out of 10 people at some point in their lives and is best known as the cause of glandular fever (infectious mononucleosis). EBV was the first human virus found to be associated with cancer.

Prof. Pender has been researching MS for over 30 years and 10 years ago proposed the idea that people with MS have impaired immunity to EBV.

First study to test EBV-specific adoptive immunotherapy in MS patient

In this latest study, he and his colleagues tested a new treatment that boosts the ability of CD8 T cells in the immune system to fight against EBV. They believe the approach, called adoptive immunotherapy, could potentially treat MS and other chronic autoimmune diseases.

The study had one patient, a 43-year-old man with secondary progressive MS. They gave him a 6-week course of the treatment, which appeared to produce no adverse side effects.

The treatment involves taking some of the patient's blood so the researchers can harvest some of his own T cells and grow them in the lab together with an EBV vaccine. Then, the boosted cells are transferred back to the patient intravenously.

The treatment was developed in the lab of study co-author Rajiv Khanna, a professor at the QIMR Berghofer Medical Research Institute, also in Brisbane, where Prof. Khanna uses it to treat patients with EBV-related malignancy.

The patient started to show signs of clinical improvement within 2 weeks of starting treatment. These improvements were still there 21 weeks later, at the most recent follow-up point.

This is the first time the treatment, called EBV-specific adoptive immunotherapy, has been used to treat a patient with progressive MS.

Scientists recently uncovered a key finding that CD4 T cells are not involved with Multiple Sclerosis progression after recent trials revealed that a depleting CD4-specific antibody failed to affect MS. The question is: did the depleting CD4 specific antibody fail to affect MS, or was the experimental design flawed? Essentially, immunologists claim that CD4 cells are at the center of the immunological research world simply because they are involved with other aspects of immune responses in order to be able to do what they do.

The researchers separated patients with SPMS into two subgroups: SP-1, which had a short duration of relapsing-remitting MS, and SP-2, which had a long duration of relapsing-remitting MS. They discovered that SP-1 patients upregulated many immune genes, within the TCR and toll-like receptor (TLR) signaling pathways. SP-2 patients demonstrated down regulation of immune genes in comparison with healthy controls. They also found an SP-1-specific transcriptional signature of 3 genes which includes TLR4, TLR2 and chemokine receptor 1. These genes had a higher surface protein expression in SP-1 than SP-2. After researchers stimulated TCR for 2 days, only SP-1 showed a progressive linear increase in TLR2 and TLR4 protein expression.

The researchers suggest that changes in naïve CD4-T-cell biology, particularly that of TCR and TLR signaling pathways, identify MS patients with a rapid conversion to secondary progression. This is important because this identifies long-term disability in MS. In fact, certain proteins are in higher concentration on T cells from progressive MS patients that progress faster. What are these proteins doing you ask? That is not known as this time, however Toll-like receptors involved with microbe recognition and infections are important to the rate of progression. We know that blocking CD4 activity doesn’t stop progression, but the question is whether it changes the slope (rate of change). We expect to find this answer from the SP1 and tysabri trials.

The Dirty Truth About Workplace Discrimination

Even when you love your job, there are occasional days when nothing sounds better than a long vacation. But when you’re living with multiple sclerosis, workplace complications can take on a more serious tone. Multiple sclerosis most often strikes young adults in the prime of their careers, and though some sufferers decide to leave the workforce, financial need or personal satisfaction keeps many other MS patients working long past their initial diagnosis.

Unfortunately, the ugly head of discrimination can rear its head when disability enters the workplace. Although the United Nations ratified the Convention on the Rights of Persons with Disabilities in 2008—an international human rights treaty that protects people with physical or emotional disabilities from discrimination in any aspect of daily life—and the Convention has been ratified by 158 nations around the globe, MS sufferers still frequently encounter ignorance, anger or impatience when it comes to their rights in the workplace.

Just ask Randall Hurst, hired to work at a car dealership in Texas, with the promise of partnership ahead. But once Hurst was diagnosed with MS, and informed his managers of the condition, instead of partnership, Hurst was subjected to harassment and insults until he finally resigned. He won his lawsuit, but some MS patients are too discouraged to pursue legal action even after blatant discrimination.

Up in Smoke: My Thoughts on Multiple Sclerosis & Smoking

This is one of those topics that makes me itchy. Before you even begin to speak about the topic, you sound judgmental. “Oh, she’s writing about multiple sclerosis and smoking, she’s judging me.”

So let me start by saying that I used to smoke. And, what’s worse, it was after I was diagnosed and was into the whole juicing thing and taking control of my MS by eating well. I would sneak into my car and sneak fags. It was time alone, and it was this one BAD thing I could do for myself when all I was doing being GOOD. I was so tired of being good.

We all approach this disease in our own personal way. You do what is right for you. I think maybe for me, smoking was a way to reach back and still feel a little bit like my old, pre-MS self. Yet I was not my old, pre-MS self, and that was something I needed to reconcile. I also have a confession that I will share with you, but first let me get into the topic at hand. They say that knowing is half the battle, and I do believe we all should know the effects smoking has on our disease and its course.

MS Societies across the world have been delving in to the topic of smoking and MS. The National MS Society in the United States seems to have delved the deepest and have come up with two big effects that are important to know:

Smoking May Increase the Risk of Developing MS and May Speed Disease Progression

The first big study was a Norwegian study that suggested a correlation between smoking and the onset of Multiple Sclerosis. This 2003 Norwegian study was published in Neurology, and showed the risk of MS was significantly higher among smokers than among those who had never smoked. In addition to this, a 2005 paper in the journal, Brain, supported the link between smoking and the risk of developing MS, and suggested that smoking may be a risk factor for transforming a relapsing-remitting clinical course into a secondary-progressive course.

Smoking May Temporarily Impair Neurologic Function

An older, smaller, and uncontrolled but still noteworthy study was published in 1987, which also explored smoking and neurological function. Thirteen MS patients who spanned the disability spectrum had their motor performance measured immediately before and after smoking a cigarette. Eleven of these patients showed a temporary deterioration in muscle strength or coordination immediately after smoking. However, no placebo groups were tested.

You must be mindful that these results are based on uncontrolled observations of a very small group, and no definitive conclusion can be drawn from them. They do suggest, however, that smoking may at least temporarily impair neurologic function. Much more research is needed, but it is interesting to think that smoking might actually have an immediate impact.

Remember, I’m no one’s role model. And here is my big confession! If I’m out for a drink, I will still sometimes smoke a fag here and there. But I am not a habitual smoker. How do I defend such a thing? I guess, moderation? I’m young and I believe a bit of mischievous fun is good for my soul, even with MS. No, ESPECIALLY with MS. I’m already far too serious! I’m just a young woman trying to navigate this world with MS ... and sometimes with a fag in my hand.

New indicator molecules visualise the activation of auto-aggressive T cells in the body as never before

Biological processes are generally based on events at the molecular and cellular level. To understand what happens in the course of infections, diseases or normal bodily functions, scientists would need to examine individual cells and their activity directly in the tissue. The development of new microscopes and fluorescent dyes in recent years has brought this scientific dream tantalisingly close. Scientists from the Max Planck Institute of Neurobiology in Martinsried have now presented not one, but two studies introducing new indicator molecules which can visualise the activation of T cells. Their findings provide new insight into the role of these cells in the autoimmune disease multiple sclerosis (MS). The new indicators are set to be an important tool in the study of other immune reactions as well.

Inflammation is the body’s defence response to a potentially harmful stimulus. The purpose of an inflammation is to fight and remove the stimulus – whether it be disease-causing pathogens or tissue. As an inflammation progresses, significant steps that occur thus include the recruitment of immune cells, the interactions of these cells in the affected tissue and the resulting activation pattern of the immune cells. The more scientists understand about these steps, the better they can develop more effective drugs and treatments to support them. This is particularly true for diseases like multiple sclerosis. In this autoimmune disorder cells from the body’s immune system penetrate into the central nervous system where they cause massive damage in the course of an inflammation.

In order to truly understand the cellular processes involved in MS, scientists ideally need to study them in real time at the exact location where they take place – directly in the affected tissue. In recent years, new microscopic techniques and fluorescent dyes have been developed to make this possible for the first time. These coloured indicators make individual cells, their components or certain cell processes visible under the microscope. For example, scientists from the Max Planck Institute of Neurobiology have developed a genetic calcium indicator, TN-XXL, which the cells themselves form, and which highlights the activity of individual nerve cells reliably and for an unlimited time. However, the gene for the indicator was not expressed by immune cells. That is why it was previously impossible to track where in the body and when a contact between immune cells and other cells led to the immune cell’s activation.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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